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ISCTM 2020 Autumn Conference- Speakers’ Corner

Thank you for agreeing to participate as a presenter and/or chairperson at the upcoming ISCTM 2020 Autumn Conference. This page contains all the links you will need for submitting information to the ISCTM, as well as information we hope you find helpful for your planning. 

Dates/Location
21-25 September 2020
Virtual Meeting

STEP 1:  Complete the Online Confirmation and Agreement

STEP 2: Please Email Biographical Paragraph and Photo

2500 characters max (including spaces)

STEP 3: Register for the Meeting

Meeting announcements will be sent mid June. At that time, you will be asked to process registration.  Your registration fee will be waived.  

STEP 4: Please Email Abstract

Abstract, for inclusion in the program book, should be submitted after the first session development call with chairs, but no later than 11 August 2020. Abstract should be in paragraph form, < 300 words and contain no tables.

STEP 5:  Presentation Slide Requirements and Submission Schedule

— Template: Widescreen format (16×9); company/university logo to appear only on the first slide.  ISCTM will supply a slide template for your use, however, use of this template is not required.  REMINDER: Disclosures must be included in slide presentation.
—Draft: Chairs will advise according to your session’s agenda development telecon schedule.

— Final: Slides will be due mid to end of August. Timeline will be advised on speaker development calls. 

STEP 6:  Chairs/Co-Chairs – Publication Information

To facilitate dissemination of information discussed during ISCTM meetings, we encourage publications from ISCTM sessions. Chairs will discuss during the session development calls. (ISCTM Publication Guidelines)

 

Agenda at a Glance  
The COVID-19 pandemic has led to substantial changes in the way clinical trials are being conducted and this has impacted on planning for the future as well. Many current trials are on hold until alternative assessment strategies are in place and it is clear that remote, as compared to in-person, recruitment, assessment, and trial monitoring may a critical part of future clinical trials in CNS areas. As a result, the ISCTM has been leading a reaction to this crisis by contributing to the discussion of how changes in trials can be feasible for sponsors and acceptable to regulators. As a result, for this upcoming meeting in Autumn 2020, all speakers in all sessions will address, to a greater or lesser extent, how remote assessment would impact on their specific topic area. In addition, we are examining the possibility of adding presentations or discussion groups that specifically target the topic of remote trial conduct.
Monday 21 September 2020  10:00 am – 2:00 pm EDT  
Session 1: Implications of pediatric initiatives on CNS drug development for all ages – 2020 and beyond
Chairs: Gahan Pandina/Joan Busner/Ravi Anand
  Introduction to pediatric aspects of drug development Joe Horrigan
  Drug development – the chicken or the egg?  How the approach to research in pediatric populations affects the drug development process Gahan Pandina
  Discussion  
  Unique issues in outcome measurement when including pediatric populations Christine McSherry 
  Discussion  
  IRB/Ethics committee requirements for pediatrics and how these may affect drug research Alison Bateman-House
  Discussion  
  Regulatory challenges when including pediatric populations Tiffany Farchione
  EU regulatory perspective Pending
  Expanded discussion on other needs to facilitate peds-first drug development approach Speakers
Tuesday 22 September 2020  10:00 am-2:00 pm EDT
Hot Topic Session- Pending

Session 2: Special challenges in pediatric drug development
Chairs: /Phil Harvey/Gahan Pandina/Joan Busner
  Background Chairs
  Measurement of cognition / mental health in pediatrics: How do we measure a moving target? H. Gerry Taylor
  Discussion  
  Securing patients – value of precompetitive consortia Meg Grabb
  Discussion  
  Rater training for pediatric trials: pathology, parents, placebos, pandemics Joohi Jimenez-Shahed
  Discussion  
  Panel discussion Tiffany Farchione
Speakers
Wednesday 23 September 2020  10:00 am – 2:00 pm EDT  
Session 3: Borderline personality disorder: Clinical development challenges and opportunities in the current regulatory environment  Chairs: Michael Ropacki/Gary Sachs
  Introduction Chairs
  Methodological issues and barriers faced in BPD clinical development Michael Ropacki
  Discussion  
  Beginning with the end point in mind  Gary Sachs
  Discussion  
  Opportunities for innovative adaptive clinical trial designs Ben Saville
  Discussion  
  Regulatory feedback and commentary on BPD clinical development  FDA Pending approval
  Discussion  
  Panel discussion Speakers
  Summary Chairs
Thursday 24 September 2020  10:00 am – 2:00 pm EDT
Session 4: Patient centricity: Design and conduct of clinical trials in orphan diseases
Chairs: Joan Busner/Gahan Pandina/Ravi Anand
  Background Simon Day
  Discussion  
  Case studies Eva Kohegyi
Atul Mahableshwarkar
  Discussion  
  Regulatory comment FDA Pending approval
EMA Pending
  Patient centricity as means of helping orphan disease trials succeed: What has worked well Judy Dunn
  Discussion  
  Including families in protocol design, protocol simulation, identification of meaningful clinical aspects, with patients    Traceann Rose
Pending: Parent/Participant
  Panel Discussion Expert  Discussant: Simon Day
Speakers
Friday 25 September 2020  10:00 am – 2:00 pm EDT  
Session 5: Toward personalized medicine: Methodologic challenges in implementing clinical trials
Chairs: Nina Schooler/Steve Marder
  Introduction Nina Schooler
  Opportunities from genomics for advancing precision psychiatry Roy Perlis
  Discussion  
  Adaptive enrichment designs: Modifying pre-specified enrollment criteria Ron Marcus
  Discussion  
  Advances in clinical characterization, prediction and remediation through the application of machine learning Isaac Galatzer-Levy
  Discussion  
  Assessment of clinical profiles and outcomes in personalized medicine  Robert Gibbons
  Discussion  
  Regulatory perspectives Pending
  Panel discussion and summary   
  Meeting adjourns
 

ISCTM Contact Information

Philip Harvey Chair, Scientific Program Committee
Carlotta McKeeExecutive Director, ISCTM
Mary Bea HardingAssociate Director, ISCTM
Linda Hutchinson – Project Manager, ISCTM
Phone:  +1.615.383.7688